MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLYDESDALE 8X45MM TRIAL

Model Number 9734653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paraplegia (2448)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

The tool has been requested for product analysis.Patient weight will not be provided due to (b)(6) confidentiality laws.The initial reporter's name will not be provided due to (b)(6) confidentiality laws.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during an olif procedure.It was reported that the physique of the patient was good, and a concave incision was used, so it was difficult to develop.After dissecting the l3 and l4 intervertebral disc under the navigation, the trial was inserted.This caused a free run emg to appear in the monitoring, and both mep and sep began to fall.As a result, the procedure changed to a plif from the posterior side instead of the anterior side.The patient was paralyzed in both lower limbs.There was a delay of less than an hour.

Event Description

Reference manufacturing report # 1723170-2020-02815 for any new information.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE 8X45MM TRIAL
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10763395
• MDR Text Key: 213902183
• Report Number: 1723170-2020-02845
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9734653
• Device Catalogue Number: 9734653
• Device Lot Number: 121016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 55 YR